We are fat, sick and tired because of the way we live. Doctors agree in theory that a healthier lifestyle is the key to prevention. But in practice they rely on drugs. The sane solution is being serious about tackling the cause.

By Jerome Burne

A couple of weeks ago I wrote about a remarkable study, just published in the BMJ which had found that over half of the new cancer drugs released onto the market in a four year period by the EU drugs regulator had no good evidence that they were effective.

In other words, there was also no evidence that their benefits outweighed their risk or that they were value for money.

I’ve now found what a disastrous effect this policy has been having. Two years ago the same author investigated the benefits of ‘the increasingly aggressive pharmacological treatment of patients with advanced, incurable cancer’. Her conclusion? ‘It is associated with poorer quality of life and death, regret, financial hardship and possibly shorter survival.’

The author is Dr Courtney Davis, senior lecturer in the Department of Global Health and Social Medicine, King’s College London and she explains what is driving this appalling result. ‘An inadequate regulatory system supported by the practice of systemically misinforming patients about the effectiveness and safety of these treatments.’

Attitude to non-drug treatments blatant hypocrisy

Assuming that Davis’ detailed and serious academic research is backed up, the attitude of regulatory authorities such as the American FDA to non- drug treatments is the most blatant hypocrisy.

Last week the FDA warned firms promoting and selling cannabis oil as a possible cancer treatment to stop on pain of having their products seized because such substances had not been subjected to: ‘FDA evaluation of whether they work, what the proper dosage is ….. or whether they have dangerous side effects or other safety concerns.’

This, the press release continued, contrasted strongly with the claims made for cancer drugs: ‘They have been carefully evaluated for safety, efficacy, and quality, and are monitored by the FDA once they’re on the market.’

If only they were. Davis’ work makes it clear that the FDA’s description of drug regulation is a wish-list that has little to do with the reality.

What makes her research so compelling and alarming is its detached, professional objectivity. Her papers are not rants by someone with a cancer treatment to sell but careful and thorough sociological analyses based on 60 ‘semi-structured interviews’ with ‘regulatory agencies, patient groups, cancer specialists, journalists and others in the business.

Optimistic assessment of drug benefits

The point is not that non-drug treatments should not be tested but that the drugs should simply be held to the same standards the authorities demand for non-drugs in the name of patient safety. At the moment it seems clear that they are not.

Patients are certainly getting more drugs. One UK study found that between 2003 and 2010 there was a 67 per cent increase in the number of chemotherapy courses given to patients with advanced solid tumours.

So was this because treatments were improving, allowing for more effective combinations? This was certainly the line taken by the regulatory agencies in the USA and the EU which claim hat between a third and one half of all new treatments ‘offer important therapeutic advances over existing treatment options’

Most of these drugs are tried on patients who have been given everything else and run out of options because, so the theory goes, getting the new treatments to them quickly allows them to live longer with an improved quality of life. The American FDA, for instance, estimates that over half of all new treatments approved between 2010 and 2012 ‘represent important advances in safety or effectiveness.’

Patients suffer poorer quality of life regret and death

This is not, however, what the data Davis has gathered, is telling her. ‘The benefits offered by new drugs may not match patients’ expectations or informed preferences,’ she writes. ‘Aggressive use of chemotherapy towards the end-of-life is associated with poorer quality of life and death, regret, financial hardship and possibly shorter survival.’ The reason is that benefits of new drugs are marginal for most patients and their toxicity is sometimes severe.

Clinicians sometimes respond to this challenge by saying end-stage cancer patients are often prepared to accept this poor risk/benefit ratio. But, as Davis makes clear, that is only because they haven’t been given a true picture of what is likely to happen.

When researchers ask them what sort of benefits they expect their replies include that the chemotherapy may cure them (it won’t) and that they expect to gain between 18 and 36 more months of survival – two to three months is more likely at best. In fact some studies have found that these patients are more likely to survive longer if they don’t get chemo.

But the problem is not just that patients aren’t being told the truth about what their treatment involves – what responsible clinicians should do – but submitting patients to yet another quite possibly ineffective toxic drug regime denies them the more appropriate alternative of palliative care. This is a humane and evidence based alternative to chemo which won’t cure because ‘most metastatic tumours are incurable’ or aggressive drug combinations that are unlikely to help.

Government allies with commercial interests

So why, Davis asks, are patients so frequently getting treatments not in their best interests? Her conclusion is chilling. It is down to a combination of drug company interests (unsurprising) and the interests of the government (alarming).

Before a new drug can be released onto the market it has to be tested in an expensive, drug-company-controlled randomised trial. The pressure to produce favourable results is obviously intense.

In theory this should be balanced by an independent regulator who would assess trials’ reliability. ‘Unfortunately’, Davies writes ‘current standards for market approval in the US and the EU fail to ensure that new anticancer therapies offer clinically meaningful benefits patients.’ The claim the FDA makes about the regulation of drugs – that they are ‘carefully evaluated for safety, efficacy’ is patently a myth.

So why are the regulatory standards so permissive? The official justification for relaxing them several years ago was that it would speed up the time it took to get new, improved life-saving therapies to patients. More critical observers explained it as the result of drug company financial clout. They pay the agencies for their licences so they call the tune.

In fact the responsibility goes even higher. It was official government economic policy both in America and the EU and the results for patients and clinicians were disastrous. ‘The (changes) were implemented by regulatory authorities under pressure from the US Congress and EU Commission,’ writes Davis ‘which were in turn driven by a determination to boost the relative economic competitiveness of their life sciences industries within the global economy.’

So rather than attempting to balance the needs of the patients for safe and effective treatments with the profit-driven motive of the corporations, the governments were putting their weight behind industry. As a result drugs have effectively become the only way to tackle cancer.

Research ignores what patient’s want

Davis explains how publicly funded bodies and charities have been driven to ‘concentrate resources on research to support drug discovery and development….(making it) increasingly difficult for researchers to attract funding for applied clinical research questions that do not involve drugs. ’

The result is national research programs that pay virtually no attention to what patients and clinicians actually want. ‘When cancer patients in the UK were asked to rank their research priorities, participants were more likely to prioritise research on psychosocial issues – such as the impact of disease, how to live with it and other support issues – than research on anticancer treatments.’

The idea that drugs are the only way to beat cancer, supported by the combined resources of government and industry is then backed up by intensive PR. ‘As well as exaggerating the benefits of new drugs treatments, public discourse about cancer research is overwhelmingly positive and hopeful,’ writes Davis. Almost totally ignored are the analyses finding evidence of: ‘biased and incomplete reporting of trial results.’

Davis’ research makes for uncomfortable reading. We are all terrified of cancer, not just the disease but the treatments that come with it. We want to be told treatments are safe and effective, to believe in the experts. But what if such comforting beliefs result in widespread damaging over-treatment and the frequent use of drugs that may well not be beneficial at all while promising alternative approaches are deliberately starved of funds?

Davis’ report last month about drugs being licenced with no good evidence of effectiveness was shocking but it was completely predictable from the picture she had painted two years earlier. It was inevitable that the shoddy review system she had described would lead to ineffective drugs being released into the system The real scandal was that her warning bells are simply being ignored in the clamour about ‘miracle drugs’, ‘science at a crossroads’ and ‘new eras’.

What needs to be done

In other industries, reports of poor regulation or lack of oversight putting lives at risk –deadly exhaust emissions, abuse of vulnerable patients or even falsified sell-by-dates on foods – at least trigger demands that ‘something must be done’, often followed up by hearings and further investigation. The cancer industry seems able to flout the rules with impunity.

Davis’ work is obviously not the final word but it should be a start in calling for something better. The approach taken by regulators to non-drug treatments might provide a useful place to start.

This is how the FDA described their regulatory processed with regard to cannabis oil: “We have an obligation to provide caregivers and patients with the confidence that cancer treatment claims have been carefully evaluated for safety, efficacy and quality and are monitored by the FDA once they’re on the market.” Doing all these things for the drugs would be a great improvement.

What if the regulators and the companies don’t comply? ‘Failure to correct the violations promptly may result in legal action, including product seizure and injunction.’ Sounds like just the sort of radical approach that is needed.

Jerome Burne

Jerome Burne is the editor of HealthInsightUK. He is an award-winning journalist who has been specialising in medicine and health for the last 10 years and now works mainly for the Daily Mail. His most recent book “10 Secrets of Healthy Ageing” was written with nutritionist Patrick Holford. He blogs at “Body of Evidence” – jeromeburne.com. 2015: Finalist for 'Blogger of the Year' award from Medical Journalists' Association.

10 Comments

All deeply worrying, but one factor does seem to be missing – and that is patient demand. Almost every day, there is something in the news, or some petition circulating to get the latest drug for a terminally ill patient. Maybe if some of these patients were better informed about the effects and efficacy, this would be lessened, but it’s still a contributing factor.

Doctors caused disease largely resulting from drug toxicity.Good foods set you up for strong immunity which is your greatest asset.Mainly things that grow directly in the soil.These keep your blood healthy, only produce waste acids at the rate you comfortably cope The food we eat is like medicine.It gives our bodies the energy they need to function well.Take responsibility to become as healthy as you could.Diet plays a vital part in promoting good health and well being.Make the connection between good food choices, and poor food choices and bad health…We all have up to 100 trillion cells in our bodies, each one demanding a constant supply of daily nutrients in order to function optimally.Food affects all those cells, and by extension every aspect of our being; mood energy levels food cravings, thinking capacity sleeping habits.Unhealthy diet increases the risk of depression and mood swings. Read labels even though recently in the Uk, the Government food standards agency enforced new rules to stop manufactures of processed food confusing us with inaccurate descriptions and labelling lies.Despite this, studies show that food labels can still be confusing and misleading for consumers.You don’t have to be a nutritionist Patrick Holford book is very helpful or visit your local library.People with deep-seated physical problems want to blame everything on someone or some imaginary cause.You have to admit that you alone are responsible for your precious life.This is a cold hard world .There is a price tag on everything in life.

When I see the way our media obsess about subjects that are minute in comparison, I wonder why there is such silence. Why aren’t Panorama or other serious players onto this? Where is Dr Michael Moseley and his BBC team? Probably looking at something pretty trivial in comparison.

The disgraceful way patients are misled into becoming pharma customers, instead of perhaps enjoying a few months of decent quality of life with loved ones, is a complete betrayal by the medical profession and regulators. The dishonest way ‘consent’ is given is clearly illegal because the consent is clearly not informed or remotely balanced.

Given proper information, many people would opt out of the seemingly hopeless round of hospital appointments, drugs and side effects. Most people don’t want to spend the last part of their life in this miserable way, if they know they are getting drugs with little or no benefit to balance against all the downside.

I think the awful truth is that whenever a huge regulatory bureaucracy is created, it facilitates corruption. For example, our complex tax system has spawned an army of tax avoidance specialists, which mean that the most wealthy can avoid almost all their tax. Ever more regulatory bureaucracy actually increases the opportunities for corruption (another good reason for Brexit!) The reason is obvious, the only people who ever fully understand the regulations are those who create them and those who devise ways round them. Indeed former rule creators often get lucrative jobs as rule evaders!

The real problem, is how to cut through this process without creating yet another layer of bureaucracy which will inevitably make matters worse.

David, complying with informed consent would be a big start. That’s already the law, but is clearly widely ignored. We must insist that people are given the truth and let them decide what they want to do. It would shorten a few waiting lists for unpleasant and not very useful treatments. Specialists find that too threatening to jobs and pockets.

Nobody like to be misled, I would like to change the health care system attitude.The reason there is no correlation between people waiting is likely to be because neither the health care system nor doctors are making much impact on the causes of disease.This might be because if you train to be a doctor you learn lots about how to treat disease but you’ll learn next to nothing about what health is and how to have lots of it.Some people never get sick and always full of energy find out how Patrick Holford.Knowledge is a power nobody can take away from you if you can read you can educate yourself.We all want a life worth living.I personally take responsibility my health is in my hands.Despite all our amazing technology, they don’t have care for many conditions that afflict us heart disease high blood pressure diabetes the list is endless, Some people may have brought on the troubles because they were ignorant of the great nutritional laws of life.We are not necessarily what we eat .We are what we digest, absorb and assimilate, physically and emotionally and mentally.Even with a comfortable home and adequate income, you need a personal purpose to engage your talents fully(not sitting in around the hospital waiting for an appointment.Respect yourself enough to know you deserve the very best.We have no influence when we enter this lifeworld and know little about when our natural death will occur.Everyone is entitled to the best possible life no matter what challenges, I did my own research about life I like the humanistic approach such as Carl Rogers viewpoint that humans can become aware of their difficulties and have the capacity to move towards psychological equilibrium.Doctors should aim higher and be more concerned with potential growth in man.What we nurture in ourselves will grow: that is nature’s eternal law.You become what you think about most of the time.Best wishes take care your precious life.

I think those readers who are being treated for cancer, or have a loved one undergoing treatment would be greatly helped if you were a bit more explicit about which drugs are ineffective, or if you could provide a good link to such information. I guess people also have no idea how many rounds of treatment they should reasonably endure.

David, the statistics don’t look good to me, particularly for most cancers. I think most people going for chemotherapy are told none of this.

A meta-analysis published in 2004 explored the contribution of cytotoxic chemotherapy to five year survival in 250 000 adults with solid cancers from Australian and US randomised trials.3 An important effect was shown on five year survival only in testicular cancer (40%), Hodgkin’s disease (37%), cancer of the cervix (12%), lymphoma (10.5%), and ovarian cancer (8.8%). Together, these represented less than 10% of all cases. In the remaining 90% of patients—including those with the commonest tumours of the lung, prostate, colorectum, and breast—drug therapy increased five year survival by less than 2.5%—an overall survival benefit of around three months.

There are no miracle cures …except the miracle cures that nature performs.You cannot get something for anything.Highe health must be earned no one can cure you ..no one can banish your ailment. Health building requires individual discipline.I am aware a Dublin doctor who lives in Howth by the name John Kelly he Encourages patient to take over the operation of their body I had never seen anything like patient cancer had disappeared in full. Elaine Nussbaum was given two weeks to live Every bone in her body had been riddled with cancer and she could barely walk, talk, breath, sit or stand.The hospital sent her home to die.They could do no more for her.On her deathbed, a friend decides to spoon -feed hear an esoteric diet called macrobiotic .This incorporated natural vegetarian foods like brown rice, vegetables, seed, beans soups.With one month, Elaine began to gain strength.With two months, she felt like she was no longer ill.She then went back to the hospital for a test and the doctors discovered that her cancer had disappeared in full.They had never seen anything like it.The hope of humanity lies in the prevention of degenerative and mental disease,not in the care of their symptoms.